Target Amphetamine/Methamphetamine-r (Reader Meth)
by V-Tech, Inc. 510(k)
Active
510(k) K910739
Overview
Target Amphetamine/Methamphetamine-r (Reader Meth) is an enzyme immunoassay device intended to measure amphetamine in plasma and urine. The device is used to diagnose amphetamine use or overdose and to monitor amphetamine levels for appropriate therapy.
The device is supplied as a reader system and is intended for single use. It is not specified as sterile or reusable. The device is regulated under FDA 510(k) clearance and is classified as a Class II medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910739 | Date21 Mar 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DKZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3100
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from V-Tech, Inc.
Questions
What is the Target Amphetamine/Meth Reader Meth device used for?
This device is an enzyme immunoassay intended to measure amphetamine levels in plasma and urine. It is used to diagnose amphetamine use or overdose and to monitor amphetamine levels for appropriate therapy.
How is the Target Amphetamine/Meth Reader Meth device supplied?
The device is supplied as a reader system and is intended for single use.
Is the Target Amphetamine/Meth Reader Meth device sterile or reusable?
The device is not specified as sterile or reusable.
What is the regulatory status of the Target Amphetamine/Meth Reader Meth device?
The device is regulated under FDA 510(k) clearance and is classified as a Class II medical device.